This disclosure relates in general to a flow delivery system that delivers material such as a biomaterial into a body, and in particular, to a syringe body for delivery of an aqueous solution containing a biomaterial or a mixture of a biomaterial and a biocompatible fluid lubricant.
This disclosure also relates to a flow delivery system, including a rotating grip or flange for the upper portion of the syringe. Needles on the syringes have a beveled distal end that creates a sharp point. The finger grips or flanges that allow the surgeon to position their index and middle finger on the body of the syringe while pushing the plunger with their thumb are commonly affixed to the syringe body. Some surgeons, including cosmetic and plastic surgeons, prefer to position the bevel in a specific direction, such as facing upward away from the skin or facing downward toward the skin depending on the procedure. When the finger grips are affixed to the syringe body, the surgeon must rotate the needle in order to configure the syringe so that the bevel on the needle is pointing in the desired direction. Many needles are engaged with the syringe body and leur by means of threads, and by rotating the needle, it is possible to loosen the connection between the needle and syringe body thus causing the needle to disengage under pressure. When disengaged while under pressure, the needle can launch from the distal end of the leur creating a sharp projectile.
The present disclosure further relates to shields for syringes such as a cover/container for a needle, also known as a cannula and hub assembly having a hub portion and a cannula portion. Moreover, the present disclosure is directed to an interface between the leur and the cannula as well as to the interface between the needle hub and the leur. Often a plenum results in the area where a needle assembly (cannula and hub) meets a syringe assembly (outer shell and leur). Certain situations can develop in which pressure builds up in the plenum and can cause a needle tip to become disengaged from the leur. When caused to disengage while under pressure, the cannula and hub assembly can launch from the distal end of the leur creating a sharp projectile.
Moreover, this disclosure concerns a system that includes a filter that breaks up or downsizes particles of material that are larger than desired (e.g., a relatively large agglomerated mass of the particles) for more effective delivery of the aqueous solution into the body.
Medical procedures often involve the non-surgical implanting of biomaterials into the body. An example is the injecting of a dermal filler material such as collagen through the use of a syringe and needle. The biomaterial can be solid and load-bearing and is typically suspended as an aqueous solution of the biomaterial particles. The solution is then injected with a syringe through a needle. For precise placement of materials into the facial dermis, a very fine cannula, e.g. 27 gauge (0.0075″ inside diameter or ID) to 30 gauge (9.0055″ ID), is preferred. These relatively small ID cannulas limit the diameter of the suspended particles that may pass through the cannula orifice during product delivery. The diameter of the particles of a product will typically range from 1-20 microns (0.001 mm-0.02 mm) in length and less than 20 microns (0.02 mm) in width. Products including larger particles can have diameters in the range of 200-700 and up to 1000 microns. In general, smaller particles can be less deformable than larger particles. Moreover, the particles can be generally spherical initially and then assume non-spherical profiles during product delivery through a cannula. It has been determined that larger particles are desirable in some situations, such as for the containment of time release medication. The larger particles pose a problem when used with the smaller cannulas required in the facial derma. The larger particles can bridge or agglomerate, resulting in clogging of the small orifice cannula. Larger particles also result in a greater amount of force needed to translate the syringe plunger especially where the particles are relatively less deformable. Common syringes include a central vessel (or leur) engaged with an outer shell, a plunger and a needle. The needle can embody a cannula that is engaged with a cone shaped portion, (or hub) that is press-fit onto the leur. Various mechanical structures such as threading are employed to assist in the press fit of the cannula and hub on to the leur. A plenum resides between the exit orifice of the leur and the entrance orifice of the cannula. When material agglomerates in this plenum, and the user will tend to increase pressure on the plunger, this higher force has a tendency to be sufficient to cause the cannula and hub assembly to launch out of the syringe.
There has been substantial research and experimentation in various mechanical methods for securing a needle tip to a syringe. U.S. Pat. No. 6,613,022 B1 is a passive needle guard that includes a body having a cavity to hold a syringe. U.S. Pat. No. 7,160,311 B2 is a compression plate apparatus that enables vessels to be joined together in various configurations. U.S. Pat. No. 7,214,207 B2 is a therapeutic infusion assembly for the subcutaneous delivery of a fluid from a remote source. U.S. Pat. No. 7,214,227 B2 is a closure member, such as a set screw and complementary receiving member included in a medical implant device. U.S. Pat. No. 7,274,966 B2 is a medical fluid delivery system including an implantable medical lead including a fixation element adapted to secure the lead to a tissue site and a fluid delivery device including a tissue piercing distal tip. U.S. Pat. No. 7,250,036 is a method for using a needle assembly for intradermal injection and a drug delivery device. U.S. Pat. No. 6,520,935 is a tip cap assembly for positive sealing engagement with a tip of syringe barrel of a syringe. U.S. patent application No. 20070255225 An intradermal needle comprising a needle cannula assembly having a limiter portion, a hub portion and a needle cannula, a protective cap having a forward and rearward cap to protect and shield a needle cannula prior to an after use, and means for engaging the needle cannula assembly and the rearward cap after use. U.S. patent application No. 20070149924 is a needle assembly including a cover, an inner shield, a needle and a hub assembly is provided. After use, the cover is placed over the distal (patient) end of the needle and the inner shield can be used to cover the proximal (non-patient) end of the needle. U.S. patent application No. 20050004552 is a passive shield system for a syringe including a body, shield, spring and ring which provide an interlock of the shield in the retracted position prior to receipt of the syringe for bulk transportation and processing and wherein the user selects the timing of the release of the shield to its extended position following injection, but which assures shielding of the syringe needle following release of the syringe plunger. U.S. patent application No. 20040102740 is a safety needle includes a needle with a sharp end and a needle shield. The needle shield includes collapsible interlocking members. U.S. patent application No. 20040097882 is a shield that protects the needle of a syringe and maintains it in a sterile condition until use. As stated, larger particles bridging or agglomerating resulting in clogging of the small orifice needle, thus resulting in a greater amount of force needed to translate the syringe plunger, the higher force may cause the surgeon to tremble and slight perturbations of the hand could result. Therefore, it is desirable to have applied forces equivalent to a low viscidity Newtonian fluid.
Other applications for implanting a biomaterial into the human body include use of the biomaterial as a bulking or augmenting agent in internal body tissue, such as the tissue that defines various sphincters, for example, in the urinary tract (specifically, in the urinary outflow of the bladder into the urethra) or in the lower esophageal area connecting the esophagus to the stomach. The malfunctioning of these sphincters is usually in the form of improper or incomplete closure of the sphincters, which leads to medical conditions such as urinary incontinence and gastroesophageal reflux disease (GERD) or heartburn, respectively. Treatment of these medical conditions may include injections of a viscous material dispersed in a solution, such as collagen, in the vicinity of the associated sphincter to augment or bulk up and fortify the tissue and thereby assist in the adequate closure of the corresponding sphincter for re-establishment of normal sphincter control. Still other applications for implanting a biomaterial such as collagen into the human body include various other body passages and tissues; for example, for correcting wrinkles not only in the facial derma but in other areas of the body as well.
In these applications it is known to inject the biomaterial, typically suspended in an aqueous solution, into the human body through use of a syringe together with an elongate needle and/or catheter. This type of flow delivery system may be used as a stand alone device or in combination with an appropriate medical instrument, such as a cystoscope, endoscope or gastroscope, which instruments are utilized to view the tissue in the affected area. However, as the length of the elongate needle and/or catheter increases, the amount of the force required to properly deliver the suspended mass aqueous solution of biomaterial to the desired body tissue area also increases. With known flow delivery systems, this increased amount of required force can cause problems both with the extrusion of the biomaterial through the flow delivery system and also with the intrusion of the biomaterial into the tissue. Oftentimes poor intrusion into the body tissue is the result of poor extrusion through the flow delivery system.
There also has been substantial research and experimentation in various chemical compositions to reduce plunger force in a syringe and needle and/or catheter flow delivery system. An area commonly researched is the ability to introduce lubricity between the particles through use of an aqueous suspension of a particulate biocompatible material and a biocompatible fluid lubricant. The biomaterial and lubricant are typically combined in a manner that results in a homogenous mixture. It is believed that the lubricant enhances flow in part by preventing particle to particle contact. See, e.g., U.S. Pat. No. 4,803,075. However, a disadvantage of the addition of the lubricant is that can reduce the content of the active component in solution.
Natural polymers or cross-linked biocompatible polysaccharide gels are used in various applications as bio implant material. Highly viscous material is often required, as it is more durable when implanted in the body. However, natural polymers can degrade under heat and light. The cross-linked biocompatible material contains particles and it has been found that it is important to create a set of uniformly sized particles. By properly placing the high intensity light sterilization process and/or an acoustic-wave heat and pressure process in the manufacturing system, it is possible to achieve the highly viscous end product with the benefits of acoustic and/or ultraviolet light sterilization and the benefits of acoustic and/or electrical-wave sizing, without the degradation of the viscosity that conventional methods cause.
Various methods of sterilization are known, including for example, heat sterilization, e.g., autoclaving, irradiation sterilization, e.g., using gamma radiation, and chemical sterilization. Sterilization methods that employ heat and/or pressure require that the process be interrupted and that a sufficient amount of time and energy be employed to bring the material up to temperature and allowed to cool. Sterilization by high-intensity, short-duration pulses of incoherent, polychromatic light in a broad spectrum can be accomplished in a significantly short period of time, within a closed loop system. Most target objects are sterilized or decontaminated within less than a few minutes as only a few flashes, having durations of a few seconds to less than a minute, are required. Sterilization employing high-amplitude ultrasonic sound waves to cause cavitation in a liquid can also be achieved in a short period of time and within the closed loop system. Cavitation occurs when the high-amplitude ultrasonic sound waves create gas-bubble cavities in the liquid. When the cavities collapse they produce intense localized pressures. This cavitation may be induced to destroy liquid-borne organisms, mix fluids or slurries, promote certain chemical reactions and otherwise treat fluids or materials therein.
The cross-linked biocompatible material contains particles, it is important to create a set of uniformly sized particles. The sizing of particles is commonly accomplished by a mechanical means, highly viscous hydrated gels contain particles of various sizes. Uniform sizing is important for the proper function of the bio-compatible material. Sizing can be accomplished within a closed loop system by the use of acoustic or electrical waves.
The process of manufacturing highly viscous hydrated gels comprises: forming an aqueous solution of a water soluble, cross-linkable polysaccharide; initiating a cross-linking agent, and continuing turbulent flow and mixing of the cross-linking agent the material is degassed (air bubbles removed) and then dispensed into various vessels for medical use.
Medical procedures often involve the non-surgical implanting of biomaterials. An example is the injecting of a dermal filler material such as collagen, or the use of highly viscous hydrated gels to suspend particles that carry medication. The particles of a soft tissue augmentation filler typically measure in the range of 150 micron to 800 microns. Uniform particle size is necessary for the proper function of delivery mechanisms such as a syringe. Properly hydrated particles are necessary for the performance of the biomaterial.
The sterilization process of said biomaterial typically involves some form of temperature and/or pressure-based sterilization techniques such as the use of an autoclave. It has been determined that heating and cooling of the autoclave process can change particle size and level of hydration. A properly hydrated particle will not change size after it is implanted in the body. With a properly hydrated particle, injections may be done repeatedly until the desired outcome is affected. This is referred to as 100% correction. An under hydrated particle will pull moisture from surrounding cells after implanting and wills well in size. The welling can cause discomfort so the surgeon must compensate for the under hydrated material by stopping before the desired outcome is affected, this is known as less than 100% correction.
Accordingly, there is a need for an improved flow delivery system for implanting a biomaterial into the human body, where the system does not allow for the needle tip (or cannula and hub assembly) to come disengaged from the leur portion of a syringe. There is also a need for interference with the axial motion of a cannula and hub assembly in the event that sufficient pressure is applied to cause the cannula and hub assembly to become disengaged from the syringe body. Moreover, there is a need for rotatably engaged finger grips for a syringe that are in mechanical engagement with the syringe body. Also, there is a need to provide a container for a cannula and hub assembly that houses the cannula in a sterile environment and covers the sharp end of the cannula while it is not in use as well as a need for providing a tactile and audible response to notify the user that a cannula and hub assembly are properly engaged. Another concern relates to needing a sufficient seal between the leur and hub as well as a seal between the exit orifice of the syringe and entrance orifice of the cannula to eliminate a plenum between the exit orifice of the leur and entrance orifice of the cannula which would otherwise allow unwanted forces to build up at the entrance orifice of the cannula. Additionally, there is a need for a visual cue to allow the user to confirm that the needle is properly engaged. There is also a need for a system that includes a filter that breaks up or downsizes particles of the biomaterial that are larger than desired, to achieve a more effective delivery of the aqueous solution into the body. Finally, there is a need for a process of sterilization of biomaterials without excessive heating and cooling and which facilitates the mixing of a cross-linking agent into a highly viscous hydrated gel as well as improves homogenous sizing of particles within the gel.
The present disclosure addresses these and other needs.